Alembic gets USFDA nod for Vilazodone HCL Tab used to treat depression.
New Delhi: Drug firm Alembic Pharmaceuticals on Monday said it has received a final nod from US health regulator for Vilazodone Hydrochloride tablets used for treatment of depression.
“The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vilazodone Hydrochloride tablets, 10 mg, 20 mg, and 40 mg,” Alembic said in a filing to BSE.
Indication of Vilazodone HCL Tab
Vilazodone Hydrochloride tablets are indicated for the treatment of major depressive disorder.
“The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales,” the drug firm said.
Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019.
Alembic had previously received tentative approval for this ANDA.
“Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity,” it said.
The launch of the product will be as per settlement agreement with US-based pharmaceutical firm Allergan.